Stichting Gezondheidscentra Eindhoven (SGE) Smoking Cessation Innovation.

Cigarette smoking is the most important contributor to the burden of disease in
the Netherlands, responsible for approximately 13% of all disability adjusted
life years lost. Despite the well-known health risks, 28% of the Dutch
population still smokes today. An important measure to reduce smoking is to
help more smokers to quit by increasing the
efficacy and effectiveness of smoking cessation treatments.

Two distinct types of smoking cessation treatment are individual counselling
and the use of varenicline, an α4β2 nicotine acetylcholine receptor partial
agonist that reduces tobacco withdrawal symptoms and the reinforcing effects of
smoking. In previous efficacy trials, varenicline was combined with intensive
behavioural support and it is not clear what the single contributions to the
overall efficacy of both types of treatments are. Although clinical guidelines
state that the combination of medication and counselling is more effective than
either treatment alone, the scientific evidence for this conclusion is scarce.
Furthermore, no studies on individual counselling and varenicline have been
performed so far under routine care conditions in the Netherlands. Yet, a study
directly comparing single varenicline with the combination treatment of
varenicline and individual counselling is badly needed to evaluate the effects
and the cost-effectiveness of both types of treatment in Dutch smokers.

Our proposed randomized controlled trial is the first making this head-to-head
comparison in a *real life* primary care setting in the Netherlands. The
primary research question is: does a 12-week combination therapy of open label
varenicline and individual counselling (group VC) increase the carbon monoxide
validated prolonged smoking cessation rate from week 9 through 26, compared
with 12 weeks single open label varenicline (group V) in adult daily cigarette
smokers? A minimum of 272 daily smokers of 18 years of age or older with no
contra-indications for the use of varenicline will be randomised to one of the
two treatment groups.

Secondary research question 1 is: what are the short-term health and economic
effects of smoking cessation? The short-term incremental cost-effectiveness of
the combination treatment (group VC) compared with the single varenicline
treatment (group V) will be expressed as additional costs per extra prolonged
quitter from week 9 to 52, using group V as
reference.

Secondary research question 2 is: what is the difference in compliance with the
use of varenicline in group VC compared to group V? If the combination
treatment of varenicline and individual counselling increases prolonged smoking
cessation rates, it is important to understand the mechanisms that contribute
to this effect. Increased compliance with the correct use of varenicline
related to individual counselling may be one such mechanism.

This trial will be conducted within the Eindhoven Corporation of Primary Health
Care Centres (SGE), which is a network of 10 primary care health centres
covering approximately 60,000 patients (28% of the population of Eindhoven).
Using the SGE allows testing of the treatments under real-life primary care
conditions, which is key to assessing the effectiveness of the interventions
and to future implementation of the trial results.

The design of this study will be a randomized, parallel group, open label
trial, comparing two intervention groups: the combination treatment of
varenicline and individual counselling (group "VC") and single varenicline
(group "V").
Participants from both group VC and group V will receive open label
varenicline. The medication will be prescribed open label to test its
effectiveness under real life conditions, with smokers knowing that they
receive active medication.

not applicable